A WORKING COVID VACCINE — We have the first sign that an effective coronavirus vaccine is around the corner, and it looks good. Pfizer and BioNTech's Monday news that their shot is more than 90 percent effective in an initial set of volunteers was heralded the world over. The news buoyed stock markets and brought congratulations from across the political spectrum. "I believe this is likely the most significant medical advance in the last 100 years, if you count the impact this will have in public health [and] global economy," Pfizer CEO Albert Bourla told CNBC. — But Trump lobbed baseless accusations at FDA and Pfizer late Monday night, accusing the regulators and drugmaker without evidence of withholding positive news until after the election. "The [FDA] and the Democrats didn't want to have me get a Vaccine WIN," he tweeted, along with another saying Pfizer and others "didn't have the courage" to announce the news before Nov. 3. Fact check: Bolstered guidance from FDA in early October closed the window for pre-election vaccine filings, but not for sharing positive data from trial check-ins. Because of data monitoring committees, Pfizer executives would not have seen data (positive or otherwise) until they hit certain milestones. But more on that below. — What we know. Pfizer took its first look at the trial data when 94 people were sick. That is significantly more than its original trial protocol called for — 32 people — and Pfizer attributed that to conversations with FDA about amending its trial and adding more people from different backgrounds and age groups. That boost is likely to soothe health experts but could rile up Trump allies who might argue the lower threshold could have meant data before Election Day. There are no major side effects so far, though tens of thousands of people have both doses by now. Pfizer aims to file for emergency use this month, and to deliver 100 million doses to the U.S. by March, said Alejandro Cané, the company's U.S. medical and vaccine chief. But the company has not determined when and how it would distribute doses to other countries. Pfizer has signed deals with the U.K., Canada and Japan and is in talks with the European Union. — What we don't know. There is no way to know just yet how long the vaccine actually protects people from the virus. The manufacturers will track volunteers for months and years to get that answer, but in the meantime it could be authorized with a limited understanding of how long it will work. "That is a $1 million question," Cané said. Monday's news "is only the first step in order to evaluate a vaccine's efficacy." Some health experts and scientists were perturbed by the lack of detail in Pfizer's press release. "None of us can give details because they have not released anything except for a press release that does not at all tell us about what they have actually accomplished," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and member of President-Elect Joe Biden's advisory board, said. "What they haven't done is said what percentage of those were just mild illnesses, and what percentage of those were severe illnesses." "Phenomenal news. But I continue to hate this pattern of vital scientific information coming out by press release. Let us see the data," Atul Gawande, another Biden task force member, tweeted and quickly deleted. — What's next. Pfizer is still on track to file with FDA for emergency use later this month. The company expects to share all of its data with FDA's expert panel, the Vaccines and Related Biological Products Advisory Committee. An outstanding question is when placebo patients can get the working shot. While it's typical to offer them the vaccine as soon as the trial wraps, Pfizer already pushed to offer volunteers the vaccine once it is authorized for emergency use. The problem: That could wreck chances for randomized trial results, and FDA is not a fan. "We are in open conversation with the FDA and definitely we will follow their advice, of course," said Cané. "The idea … is to find a way to maintain the integrity of the trial and at the same time, to offer the people the best solution possible which is our safe and efficacious vaccine." FDA GREEN LIGHTS LILLY ANTIBODY COCKTAIL — The FDA late Monday authorized the emergency use of Eli Lilly's antibody treatment for the coronavirus. The drug, known as a monoclonal antibody, mimics the body's natural defenses against the virus, writes Zachary Brennan. Under the EUA, adults and children under the age of 12 with mild to moderate Covid-19 symptoms but at high risk for severe illness can get the antibody therapy. Lilly has published limited data from a late-stage trial showing that the antibody reduces the amount of virus in a person's body, and seems to speed recovery. But it is not clear why the agency acted to authorize use of Lilly's antibody ahead of Regeneron's antibody cocktail. The companies applied for emergency use authorization last month within days of each other. Regeneron's cocktail is the one Trump touted as a coronavirus cure after he received it. "We continue productive discussions with the FDA around our EUA submission but don't expect action tonight," a Regeneron spokesperson said. HHS PAUSES DISTRIBUTION OF RAPID TESTS — Trump testing czar Brett Giroir said Monday the federal government is pausing further shipments of a cheap, rapid Covid-19 test to eight states until they begin distributing those they have already received. Hawaii, Massachusetts, North Dakota, Nevada, Virginia, Vermont, West Virginia and New Mexico have not begun to use tests they were sent, Giroir said. "Many of these states have really good plans, very impressive, but we just don't want the tests to be sitting in a warehouse," Giroir said. "When they start distributing the tests and utilizing them we will make sure they have plenty of whiskey and fresh horses to support their testing regimes." But at least one state on the list says it's distributing the tests . Virginia Department of Health spokesperson Cheryle Rodriguez told POLITICO the state has sent out more than 52,000 of the rapid tests and is disseminating 300,000 more starting this week to colleges, hospitals and local health departments. | 
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